JPH09108229A - Expansion resistant blood vessel plugging coil - Google Patents

Abstract

PROBLEM TO BE SOLVED: To form a closing plug at a required part in a canal/cavum in the case of disease such as an aneurysm by composing a blood vessel closing tool of a spirally wound outer primary coil which is used for closing the canal/cavum and which has first and second ends, and an extension resistive member fixed to the primary coil at several parts. SOLUTION: A spirally wound outer coil 102 is formed which has first and second ends 104, 106. An extension resistive member 108 is fixed to the ends 104, 106 respectively through the inside of the coil 102. Under specified circumstances, this member 108 is fixed to any one of the ends or at least one part between both the ends 104, 106. The member 108 is fiberous, and desirably of polumer.

Description

Detailed Description of the Invention

[0001]

The present invention relates to an implantable vaso-occlusive device. It is a vaso-occlusive coil typically composed of a primary spiral wound coil that can then be wound into a secondary shape. Central to the present invention is a stretch-resistiing member that extends through the formed lumen.
ng member), the extension resistant member being fixedly attached to the coil at at least two locations. The stretch resistant member may be formed at the coil tip at the end of the coil using simple equipment such as a soldering iron and the like. This tip typically has the same diameter as the coil body itself. The stretch resistant member is for the first purpose of preventing coil stretching during movement of the coil, for example, by retrieval or relocation after placement. The device need not have a secondary morphology, but typically has a self-forming secondary shape made from preformed primary linear spiral wound coils. External fibers can be attached to the device and can be attached to preformed linear members to increase thrombogenicity. The vaso-occlusive member also includes a braid of fibers.
id). The device is typically introduced into the body through a catheter. The device passes axially through the catheter sheath and assumes its secondary form upon exiting the catheter.

[0002]

BACKGROUND OF THE INVENTION A vascular occlusion device is a surgical instrument or implant that is typically placed in the vascular system of the human body via a catheter, which forms a part of the vascular system by forming an embolus. Blocks blood flow through the blood vessel or forms such an embolus within an aneurysm that arises from a blood vessel.
One widely used vaso-occlusive device is a spiral wire coil with windings that can be sized to engage the vessel wall. Other less stiff helical coil devices and devices including woven braids have been described.

For example, US Pat. No. 4,994,06 to Ritchart et al.
No. 9 describes a vaso-occlusive coil that assumes a linear helical form when stretched and a folded convoluted form when relaxed. The extended state is used (by passing it through a catheter) to place the coil at the desired site, and the coil is in its relaxed form (once the device is so placed, it occludes the blood vessel). Is more appropriate for). Ritchart et al. Describe various shapes. The secondary shape of the disclosed coil is
Includes "flower" shape and double spiral shape. Similarly, a random secondary shape is described.

Fiber-attached vaso-occlusive coils of various secondary shapes have been described by Chee et al., US Pat. No. 5,304,194.
No. Chee et al. Describe a spiral wound device having a secondary shape in which the fibrous member is sinusoidal and extends along the length of the coil. These coils, according to Ritchart et al., Are manufactured such that they pass through the lumen of a catheter in a generally straight form and, when released from the catheter, a selected lumen or Form a relaxed or folded shape in the cavity. The fibrous members shown in Chee et al. Increase the ability of the coil to fill the space within the vasculature and promote embolization and subsequent allied tissue formation.

There are various ways to release shaped and linear coils into the human vasculature. In addition to those patents (eg, Ritchart et al.), Which at first seem only describe the physical extrusion of the coil into the vasculature, many others for releasing the coil at specific selected times and sites There is a method. US Pat. No. 5,354,295 and its parent, US Pat. No. 5,122,136 (both by Guglielmi et al.) Describe electrolytically detachable embolic devices.

[0006] A variety of mechanically removable devices are also known. For example, U.S. Pat.No. 5,234,437 to Sepetka,
Fig. 3 shows a method of turning off a spiral wound coil from an extruder having a mating surface. Palermo U.S. Patent 5,2
No. 50,071 shows an embolic coil assembly with interlocking fasteners attached to both the pusher and the embolic coil. U.S. Pat.No. 5,261,916 to Engelson has an interlocking ball and keyway type coupling,
Figure 6 shows a removable pusher-vasoocclusive coil assembly. Twyford et al., U.S. Pat.No. 5,304,195, shows a pusher-vasoocclusive coil assembly, which comprises:
A proximally extending wire holding a ball is mounted on its proximal end and has a pusher with a similar end. The two ends are mated and disengage when expelled from the distal tip of the catheter. US Pat. No. 5,312,415 to Palermo also shows a method of ejecting multiple coils from a single extruder by using a guidewire having a section that can interconnect with the interior of a spiral wound coil. Palermo et al., U.S. Pat.No. 5,350,397, discloses a throat at the distal end.
Figure 3 shows an extruder with t) and an extruder through its axis. The pusher sheath is held on the end of the embolic coil and then expelled by pushing the axially positioned pusher wire against the member found on the proximal end of the vaso-occlusive coil.

[0007] Vasoocclusive coils having little or no inherent secondary shape have also been described. For example,
No. 07 / 978,320 to Berenstein et al. (1992)
Filed on November 18, 2011), titled "Ultra-soft embolization coil with fluid-like properties"
Coil with little or no shape is found.

None of the above devices are helical coils that include the stretch resistant member contained therein.

[0009]

DISCLOSURE OF THE INVENTION The present invention is an improvement over the conventional vascular occlusion device, which is used at a desired site in the vascular system to form an embolus for an indication such as an aneurysm. I will provide a.

[0010]

SUMMARY OF THE INVENTION The present invention is a vaso-occlusive device comprising: (i) a first end and a second end, the first end and the second end. An outer spiral wound primary coil defining a lumen therebetween; and (ii) a stretch resistant member extending through the lumen and fixedly attached to the primary coil at at least two points.

In a preferred embodiment, the device is
An arrangement tip is attached to at least one of the first end and the second end.

[0012] In a preferred embodiment, the deployment tip comprises a mechanically removable end adapted to be coupled to and disengaged from the pusher.

In a preferred embodiment, the deployment tip comprises an electrically detachable end adapted to disengage from the pusher upon application of an electric current on the pusher.

In a preferred embodiment, the stretch resistant member comprises at least one fiber.

In a preferred embodiment, the stretch resistant member comprises a plurality of fibers.

In a preferred embodiment, the stretch resistant member comprises a wire.

In a preferred embodiment, the stretch resistant member comprises a helical coil.

In a preferred embodiment, the device has a secondary form.

In a preferred embodiment, the spiral wound coil comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten and alloys thereof.

In a preferred embodiment, the spiral wound coil comprises an alloy of platinum and tungsten.

In a preferred embodiment, the spiral wound coil comprises an alloy selected from the group consisting of stainless steel and superelastic alloys.

In a preferred embodiment, the spiral wound coil comprises a nickel-titanium superelastic alloy.

In a preferred embodiment, the device comprises:
Includes a polymer containing a radiopaque filler.

In a preferred embodiment, the device is
It further comprises an external fiber material attached to the primary coil.

In a preferred embodiment, the stretch resistant member comprises a polymer.

In a preferred embodiment, the stretch resistant member comprises a thermoplastic resin.

In a preferred embodiment, the thermoplastic resin comprises polyethylene terephthalate.

In a preferred embodiment, the thermoplastic resin further forms a cap where it is located on at least one end of the primary coil.

In a preferred embodiment, the stretch resistant member is adhered to at least one end of the primary coil.

In a preferred embodiment, the cap has the same diameter as the primary coil.

In a preferred embodiment, the thermoplastic resin forms a cap at both ends of the primary coil.

In a preferred embodiment, the stretch resistant member extends through the lumen and is fixedly attached to at least one of the first end and the second end.

In a preferred embodiment, the stretch resistant member extends through the lumen and is fixedly attached to at least one site between the first end and the second end. To be

In a preferred embodiment, the stretch resistant member comprises a ribbon.

In a preferred embodiment, the ribbon comprises platinum, palladium, rhodium, gold, tungsten,
And a metal selected from the group consisting of alloys thereof.

[0036] In a preferred embodiment, the ribbon comprises an alloy of platinum and tungsten.

[0037] In a preferred embodiment, the spiral wound coil comprises an alloy selected from the group consisting of stainless steel and superelastic alloy.

In a preferred embodiment, the spiral wound coil includes a nickel-titanium superelastic alloy.

The present invention provides a vaso-occlusive device comprising a spiral wound coil formed by winding a wire into a first or primary spiral to form an outer spiral member having a first end and a second end. Is. A stretch resistant member extending through the formed lumen is fixedly attached to the coil in at least two locations.

The primary helix with the extension resistant member may be wound into a secondary configuration, preferably prior to the step of including the extension resistant member in the coil, and may be heat treated to retain that configuration. This secondary morphology may form a unique shape when released from the delivery catheter. Such a shape may fill a vascular lumen such as, for example, an aneurysm, and possibly a fistula. The stiffness of the various parts of the coil may be tailored to improve the utility of the device for particular applications. A fibrous material is woven into, tied to, or overlaid on the member.

The device is simply used by temporarily straightening the device and introducing it into a suitable catheter, the catheter having its distal opening at a selected site in the body. It is already in a certain state. The device then assumes its relaxed or secondary shape upon being pushed through the catheter and released from the distal end of the catheter into the lumen of the blood vessel.

The device is typically used in the human vasculature to form an embolus, but can be used anywhere in the human body where an occlusion, such as that produced by the device of the present invention, is required.

[0043]

DETAILED DESCRIPTION OF THE INVENTION FIGS. 1A, 1B and 1C show side partial cross-sectional (or cut-away) views of a highly desirable variation of the coil (100, 200, 210) of the present invention.

The variation shown in FIGS. 1A and 1B consists of a spiral wound outer coil (102, 202) having a first end (104, 204) and a second end (106, 206). .
We refer to this configuration as the "primary" winding or shape. These variants are stretch resistant members (108, 208, 214) shown to be fixedly attached to both the first end (104, 204) and the second end (106, 206).
Is provided. Under certain circumstances, stretch resistant members (108, 2
It is desirable to attach 08) to only one of the two ends, to at least one site between the two ends, or to none of the two ends.
Obviously, in order to achieve stretch resistance, the stretch resistant member must be attached in at least two positions on the coil.

The stretch resistant member (108) of the variation shown in FIG. 1A is fibrous and preferably polymeric. The stretch resistant member (108) can be a thermoplastic or thermoset resin and includes a bundle of yarns or single filaments, which are
0) fused on, glued to the vaso-occlusive coil (100) or otherwise fixedly attached to the vaso-occlusive coil (100). In some cases, it may also be desirable to include one or more metal strands within the stretch resistant member (108) to provide rigidity or electrical conductance for a particular application. .

The stretch resistant member (208) of the variation shown in FIG. 1B is a simple wire or "ribbon", which is a first end (204),
Soldered, brazed, glued, or otherwise at the second end (206), or at one or more points intermediate the ends of the coil It is fixedly attached.

The variation shown in FIG. 1C comprises a stretch resistant member (214) comprised of a spiral wound coil, the spiral wound coil having a first end (204) or a second end. It is soldered, brazed, glued, or otherwise fixedly attached to part (206), or to one or more intermediate locations. This form of stretch resistant member (214) provides a greater degree of lateral flexibility than the wire type variation (208 in FIG. 1B). It can be wound either in the same direction as the outer coil (202) or in a different direction. A slight disadvantage of this variant is that it stretches more when subjected to an axial stress than the variant in FIG. 1B.

The material used to construct the vaso-occlusive coil (102, 202) and the stretch resistant member (108, 208, 214) can be any of a wide variety of materials; preferably metal or A radiopaque material such as a polymer is used. Suitable metals or alloys for the wires that make up the primary coil (102, 202) and the stretch resistant member (108, 208, 214) include platinum group metals, particularly platinum, rhodium, palladium, rhenium, and tungsten.
Gold, silver, tantalum, and alloys of these metals. These metals have significant radiopacity,
And in those alloys, it may be configured so that flexibility and rigidity are properly mixed. They are also almost biologically inert. Highly preferred is platinum /
It is a tungsten alloy (for example, 8% is tungsten and the balance is platinum).

Ribbon or coil stretch resistant member (20
8, 214) may also be any of a wide variety of stainless steels that can withstand some of the radiopacity and some sacrifice in flexibility. Highly desirable construction materials from a mechanical point of view are those materials that maintain their shape under high stress. Specific "superelastic alloys" include various nickel / titanium alloys (containing 48-58 atomic% nickel and optionally small amounts of iron); copper / zinc alloys (38-42% by weight zinc). Copper / zinc alloys containing 1-10 wt% beryllium, silicon, tin, aluminum, or gallium; or nickel / aluminum alloys (36-38 atom% aluminum). Particularly preferred are US Pat. Nos. 3,174,851; 3,351,4
No. 63; and No. 3,753,700. Particularly preferred is a titanium / nickel alloy known as "nitinol". These are very robust alloys and withstand significant bending without deformation, even when used as very small diameter wires.

When a superelastic alloy such as Nitinol is used in the device, the diameter of the coil wire is greater than the diameter used when platinum or platinum / tungsten alloy, which has a relatively high ductility, is used as the construction material. It can be a significantly smaller diameter.

The coil is a radiation transmissive fiber, such as Dacron (polyester), polyglycolic acid, polylactic acid, fluoropolymer (polytetrafluoroethylene), nylon (polyamide), or even silk. Or it may be made of a polymer (or a metal thread coated with radiopaque or radiopaque fibers). When a polymer is used as the main component of the vaso-occlusive coil member, it is desirably filled with a specific amount of radiopaque material such as powdered tantalum, powdered tungsten, bismuth oxide, barium sulfate and the like.

The coil material is first of all the primary coil (102, 2
02) The primary coil is typically linear after it has been wound. Generally speaking, coils (10
2,202) is a metal coil, and if the coil is a platinum alloy or a superelastic alloy such as Nitinol, the diameter of the wire used to manufacture the coil (102,202) is 0.00025 inches and 0.006 inches. It is in the range between inches. This wire is wound on a primary coil (102, 202) having a primary diameter of between 0.003 inch and 0.025 inch.
For most neurovascular indications, the preferred primary coil (102, 202) diameter is 0.008 inches to 0.018 inches. The present inventors provide the resulting device with sufficient annulus strength to hold the device in place within a selected body part, lumen or fossa. It has been found generally that it can be of sufficient diameter to substantially dilate the wall of the site and that there is no migration from the site as a result of repetitive fluid veins found in the vasculature. .

The axial length of the primary coil is usually 0.5 cm to 100
cm and more usually in the range of 2.0 cm to 40 cm. Depending on the application, the coil may suitably have 10 to 75 turns per centimeter, preferably 10 to 40 turns per centimeter. All dimensions in this specification are given for guidance only and are not critical to the invention. However, only those dimensions suitable for use in occluding a site within the human body are within the scope of the invention.

Once the primary coil (102, 202) has been wound, the stretch resistant member (108, 208) is replaced by the primary coil (10).
2, 202) and attached to the coil as desired. Edge (104, 204, 106, 206)
Are preferably the same diameter as the primary coils (102, 202).

Suitable polymeric materials for the polymeric stretch resistant member (108) can be either thermoset or thermoplastic. Thermoplastic resins are preferred. Because they are melted and formed at the ends or ends (104, 106), they simplify the construction procedure of the tool (100). The ends may be formed using a simple tool such as a soldering iron. Thermosetting plastics are typically
It can be held in place by an adhesive. Suitable polymers are most biocompatible materials that can be formed into fibers, but polyethylene terephthalate (especially Dacr
on) and polyamides such as Nylon, polyglycolic acid, polylactic acid, fluoropolymers (polytetrafluoroethylene), or even silk. Especially suitable for a long history of safety and effective use in the human body is Da
It is a fibrous polyethylene terephthalate (PET) sold as cron.

FIG. 2A shows a partial side sectional view of one end of the coil (100) of the present invention. FIG. 2A also shows a spiral wound outer coil (102) having an end (106) formed from a previously melted fiber, which also has a stretch resistant member (114). Configure. This type of end can be considered to have slightly higher vaso-occlusive properties than a metal end. Other functional equivalents of this structure are adhesives such as epoxies and their equivalents (g
the ends (106) formed from lue), and they are mechanical in nature.

FIG. 2B shows an external knot (k) that fixes the length of the coil member (102) and prevents it from stretching.
2C shows a reformed mass of a previously melted polymer or adhesive that consists of a diameter larger than the inner diameter of the coil (102) and prevents the coil from stretching. Show. Knot (112) and block (114)
Are not shown attached to the coil (102), but may be attached to the coil.

The variations shown in FIGS. 1A, 1B, and 1C, and FIGS. 2A, 2B, and 2C are described in Ritchart et al., Supra. According to the method, it is designed to be placed by the use of pushers and catheters. Other methods (and the accompanying fittings or joints to accomplish these methods) may also be used.

For example, the end of the device is described in the above-mentioned US Pat.
It may be adapted to accept electrolytically separable joints of the type described in 5,354,295 and its parent patent 5,122,136 (both by Guglielmi and Sepetka). FIGS. 3A and 3B show partial cross-sectional views of such a modification. The vaso-occlusive coil (130, 230) is attached to a fill member (132, 232). The filling members (132, 232) preferably include a thermoplastic or epoxy formed in place, and the expansion resistant members (134, 234) and core wires (136, 23).
6) Adhere to both in turn. The core wire (136, 236) in this variation has an enlarged member embedded in the filling member (132, 232). The core wires (136, 236) are small sacrificial joints (sacrificial
Except for the joints (138, 238), they are typically insulated with a combination of polytetrafluoroethylene and parylene (polyparaxylylene). This sacrificial joint is intended to be the site of electrolysis, where the joints (138, 238) are eroded or separated and the coil is placed within the body part. Details of this variation (without extension resistant members (136, 236)) can be found in US patent application Ser. No. 08 / 367,061 of Gia et al.
(Application dated 0), which is incorporated by reference in its entirety.

FIG. 4A illustrates yet another variation of a joint for releasing the coil of the present invention into a site within the human body. In this case, the joint is mechanically arranged.
The primary coil (140) is such that one (142) is located on the end of the coil (140) and one (144) is the pusher (146).
Incorporates a mating fastener located on the end of the. The stretch resistant member (148) is fitted with a filler block (filler b).
It is attached to the interlocking fastener (142) via the lock (154). Still further, the filling block (154) includes a material (eg, a thermoplastic or an adhesive material) that can be disposed within the coil and adheres to the stretch resistant member (148). A coil assembly (150) composed of a primary coil (140), a mating fastener (142), and a stretch resistant member (148) comprises a catheter body (or sheath) (15).
2) Be placed by retracting. B in FIG.
FIG. 4A shows a variation of the device shown in FIG. 4A, which does not use a specific filler block material (154) for bonding to the stretch resistant member.

Other mechanically positionable joints suitable for use with the coils of the present invention are described below:-Sepetka
U.S. Pat. No. 5,234,437, which shows a method of unwinding a spiral wound coil from an extruder having mating surfaces.

Palermo US Pat. No. 5,250,071 (showing embolic coil assembly with interlocking fasteners mounted on the pusher and on the embolic coil).

Engelson US Pat. No. 5,261,916 (removable pusher / vaso-occlusive coil assembly with interlocking ball and keyway type connections).

Twyford et al., US Pat. No. 5,304,195 (extruder-shows a vaso-occlusive coil assembly;
It is fitted with a proximally extending wire that holds the ball on its proximal end, and has an extruder with a similar end. The two ends are engaged,
And disengage when ejected from the distal tip of the catheter).

Palermo US Pat. No. 5,312,415 (also showing how multiple coils can be ejected from a single pusher through the use of a guide wire having a section that can be interconnected with the interior of a spiral wound coil. ).

Palermo US Pat. No. 5,350,397 (showing a pusher with a throat at its distal end and a pusher through its axis. The pusher sheath is held on the end of the embolic coil and then axially. The pusher wire placed is released by pushing it against the member found on the proximal end of the vaso-occlusive coil).

All of these are incorporated by reference.

As mentioned above, the device of the present invention may have the simple linear shape shown in FIGS. 1 and 2, or it may have such a non-simple shape. FIG.
6 and 7 show so-called "secondary" shapes, where they are by the simple act of winding the primary coil onto the desired shape of the morphology, and then by heat treating the shape thus formed, It is formed from a primary coil. FIG. 5 shows a “C” shaped coil assembly (160) having a stretch resistant member (162). FIG. 6 shows a cloverleaf-shaped coil assembly (164), which also has a stretch resistant member (162). FIG. 7 shows a double loop coil assembly (166). These represent various secondary shapes suitable for the present invention.

Furthermore, these inventive devices can also be used in combination with various external fiber attachments. FIG.
Is a loop of fiber material (fila) through the coil (174).
mentary material) (172).
The partial side view of the linear modification of (0) is shown. This method of attachment is described in US Pat. Nos. 5,226,911 to Chee et al.
5,304,194, which are incorporated by reference in their entirety. Further description of the preferred fiber attachment can be found in Mirigian et al. US patent application Ser. No. 08/2
No. 65,188 (filed June 24, 1994).

FIG. 9 shows a braided cover of fibrous material.
g) a tool (18) having a (182) and a stretch resistant member (184).
0) shows a partial cutaway view. This method of wrapping the coil
No. 5,382,259 to lps et al., which is incorporated by reference in its entirety.

Fiber woven or braided tubular materials include Dacron (polyester), polyglycolic acid,
It can be made from biocompatible materials such as polylactic acid, fluoropolymers (polytetrafluoroethylene), Nylon (polyamide), or silk. The strands forming this braid should have a reasonable weight, for example, a tensile strength greater than about 0.15 pounds. The materials described can be melted or fused into coils such that they are thermoplastic. Alternatively, they are glued or otherwise fixed to the coils. The preferred material is Dacron.

FIGS. 10A-10D show a general placement method for introducing the inventive vaso-occlusive device described herein. It can be observed that these procedures are not significantly different from the method described in the above-mentioned Ritchart et al. Patent. Specifically, A of FIG.
6 shows the distal tip of the delivery catheter (310) within the opening (312) of the aneurysm (314) found within. The distal or end section of the vaso-occlusive device (318) is shown within the catheter (310). In Figure 10B, the distal end portion of the vaso-occlusive device (318) exits the distal end of the catheter (310) and is rolled into a secondary shape within the aneurysm (314). FIG. 10C shows the completion of the secondary shape formation within the aneurysm (314). FIG. 10D shows separation of the vaso-occlusive device (318) from the pusher device, placement within the aneurysm (314), and withdrawal of the catheter from the aneurysm port.

Once the coil of the present invention is in place within an aneurysm or other site, it may be the case that the coil must be moved or even withdrawn. For example, in FIG. 10D, the coil can extend into the artery through the aneurysm ostium (312). Second, occlusion in the artery is undesirable. Rappe US Patent No.
Devices such as the intravascular snare snare shown in 5,387,219 can be used to capture the exposed coil and move or retrieve it from the body. The stretch resistant member of the present invention prevents the coil from stretching into a single strand of wire and increasing the length of the coil.

Modifications of the above variations for carrying out the invention will be generally apparent to those skilled in the field of medical device design, particularly vascular occlusion devices, and are intended to be within the scope of the following claims. It

[0075]

The present invention is a vaso-occlusive coil composed of a primary spiral wound coil which can then be wound into a secondary shape, characterized by an extension which is fixedly attached to the coil at at least two points. It is to have a resistive member. The stretch resistant member may prevent stretching of the coil during movement of the coil, for example by retrieval or repositioning after placement. The vascular occlusion device of the present invention,
It can be used for indications such as aneurysms.

[Brief description of the drawings]

FIG. 1 is a side partial cutaway view showing a vaso-occlusive coil made in accordance with the present invention. A is a side partial cutaway view showing a vasoocclusive coil having a stretch-resistant member of generally linear fibers. B is a side partial cutaway view showing a vasoocclusive coil having a generally linear wire stretch resistant member. C is a side partial cutaway view showing a vaso-occlusive coil with a generally helical stretch resistant member.

2A, B, and C are side partial cutaway views showing exemplary ends of a vaso-occlusive coil of the present invention.

3A and B are side partial cutaway views of an exemplary mechanically detachable joint in combination with a vaso-occlusive coil made in accordance with the present invention.

4A and B are side partial cutaway views of an electrolytically separable joint in combination with a vaso-occlusive coil made in accordance with the present invention.

FIG. 5 shows a “C” -shaped secondary shape for the vaso-occlusive device of the present invention.

FIG. 6 is a diagram showing a secondary shape of a clover leaf for the vaso-occlusive device of the present invention.

FIG. 7 shows the secondary shape of a double loop for the vaso-occlusive device of the present invention.

FIG. 8 is a view showing attachment of an external fiber material to the vascular occlusion device of the present invention.

FIG. 9 illustrates attachment of an external braided fiber material to the vaso-occlusive device of the present invention.

10A-10D show a procedure for introducing a vaso-occlusive coil into an aneurysm as seen in other figures.

[Explanation of symbols]

100, 130, 170, 180, 200, 210, 230, 318: Vascular occlusion device or coil 102, 140, 202: Primary coil 104, 204: First end 106, 206: Second end 108, 134, 148 , 162, 208, 214, 234: stretch resistant member 112: knot 132, 232: filling member 136, 236: core wire 138, 238: sacrificial joint 142, 144: interlocking fastener 154: filling block 160: " C-shaped coil assembly 164: Cloverleaf-shaped coil assembly 166: Double loop coil assembly 310: Delivery catheter 312: Opening 314: Aneurysm 316: Artery

Continued Front Page (72) Inventor Christopher G. M. Ken United States California 94403, San Mateo, Hillsdale Boulevard 652 (72) Inventor Son Em. Gear United States California 95111, San Jose, Bengal Drive 5065 (72) Inventor Eric T. Engelson United States California 94025, Menlo Park, Enginal Avenue 401

Claims (29)

[Claims] 1. A vaso-occlusive device comprising: (i) an external helix having a first end and a second end, defining an lumen between the first and second ends. Wound primary coil; and (ii) extending through the lumen, at least 2
A stretch resistant member fixedly attached to the primary coil at one of the locations. 2. An arrangement tip attached to at least one of said first end and said second end,
The device according to claim 1. 3. The placement tip is connected to an extrusion tool,
3. The tool of claim 2 and comprising a mechanically removable end adapted to disengage from the pusher. 4. The tool of claim 2, wherein the placement tip comprises an electrically detachable end adapted to disengage from the pusher upon application of an electric current on the pusher. 5. The device of claim 1, wherein said stretch resistant member comprises at least one fiber. 6. The device of claim 1, wherein said stretch resistant member comprises a plurality of fibers. 7. The stretch resistant member comprises a wire.
The device according to claim 1. 8. The device of claim 1, wherein said stretch resistant member comprises a helical coil. 9. The device according to claim 1, wherein the device has a secondary configuration.
Tools described in. 10. The device of claim 1, wherein said spiral wound coil comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, and alloys thereof. 11. The device of claim 10, wherein said spiral wound coil comprises an alloy of platinum and tungsten. 12. The device of claim 1, wherein said spiral wound coil comprises an alloy selected from the group consisting of stainless steel and a superelastic alloy. 13. The method according to claim 13, wherein the spirally wound coil is nickel-
13. The device of claim 12, comprising a titanium superelastic alloy. 14. The device of claim 1, comprising a polymer containing a radiopaque filler. 15. The device of claim 1, further comprising an external fiber material attached to said primary coil. 16. The device of claim 1, wherein said stretch resistant member comprises a polymer. 17. The device of claim 16, wherein said stretch resistant member comprises a thermoplastic. 18. The device of claim 17, wherein said thermoplastic comprises polyethylene terephthalate. 19. The tool of claim 17, wherein the thermoplastic resin further forms a cap where it is located on at least one end of the primary coil. 20. The device of claim 1, wherein the stretch resistant member adheres to at least one end of the primary coil. 21. The device of claim 19, wherein the cap is of the same diameter as the primary coil. 22. The device of claim 19, wherein the thermoplastic resin forms a cap on both ends of the primary coil. 23. The extension resistant member extends through the lumen and is fixedly attached to at least one of the first end and the second end.
Tools described in. 24. The extension resistant member extends through the lumen and is fixedly attached to at least one site between the first end and the second end. Tools described in. 25. The device of claim 1, wherein the stretch resistant member comprises a ribbon. 26. The device of claim 25, wherein the ribbon comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, and alloys thereof. 27. The device of claim 26, wherein the ribbon comprises an alloy of platinum and tungsten. 28. The device of claim 25, wherein the spiral wound coil comprises an alloy selected from the group consisting of stainless steel and superelastic alloys. 29. The spiral wound coil is made of nickel-
29. The device of claim 28, comprising a titanium superelastic alloy.